Effect of 4 Liver Fibrosis Tests (PIIINP, CIV, LN, and HA) on the Prognosis of Liver Cirrhosis

NCT02335073 | Completed

• 1 other identifier: LFT4-LC
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Liver biopsy is the reference method for the measurement of liver fibrosis. But it has many limitations, such as sampling error and individual variation in interpreting the results. Currently, serum liver fibrosis markers have been employed as non-invasive diagnosis of liver fibrosis and evaluation of the severity of liver fibrosis. They include laminin (LN), hyaluronic acid (HA), collagen type IV (CIV), and N-terminal propeptide of collagen III (PIIINP). However, few study was conducted to explore the role of these liver fibrosis markers in evaluating the prognosis of liver cirrhosis. Our hypothesis is that LN, HA, CIV, and PIIINP in combination or alone can predict the prognosis of liver cirrhosis.

Conditions

Liver Cirrhosis

Keywords

Prognosis

Outcome Measures

Primary Outcomes (1)

• Death

  6-12 months

Secondary Outcomes (1)

• Hepatic decompensation events

  6-12 months

Interventions

Venous blood OTHER

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study population should be patients with a diagnosis of liver cirrhosis who were admitted to the Department of Gastroenterology of the General Hospital of Shenyang Military Area.

You may qualify if:

• Patients were admitted to our department.
• Patients were diagnosed with liver cirrhosis.
• Patients signed the informed consent and agreed to test serum liver fibrosis markers (PIIINP, CIV, LN, and HA).

You may not qualify if:

• Non-cirrhotic patients.
• Malignancy.
• Severe cardiopulmonary diseases.
• Severe infectious diseases.
• Other diseases with a shortened lifespan.
• Pregnant and breastfeeding.
• Poor adherence.

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

Department of Gastroenterology, General Hospital of Shenyang Military Area

Shenyang, Liaoning, 110840, China

Location

Biospecimen

Retention: NONE RETAINED

Venous blood

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Venous Pressure

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Pressure; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 7, 2015
• First Posted: January 9, 2015
• Study Start: January 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)